Kornimate/medical-research-clean huggingface dataset:
etoricoxib for postoperative pain after thyroid surgery

Conditions: Acute Pain

Summary: the purpose of the study is evaluate the analgesic efficacy and safety profile of the cox-2 specific analgesic etoricoxib (arcoxia®) when administrated pre and postoperatively for controlling pain in adult patients undergoing thyroid surgery. patients will be followed up in the immediate postoperative period, during the first postoperative (pod) day and in pod 2, 3 and 7. it is expected that with the addition of etoricoxib, patients will experience less pain during the overall postoperative period and also a better quality of recovery when compared with the traditional analgesic regimen.


Eligibility criteria:
inclusion criteria: * age \>18 and \<70 years * body weight within normal ranges * ability to understand the use of pain assessment scales and the pca device exclusion criteria: * known allergy to any of the drugs utilized * contraindication to opioid and non-opioid analgesic drugs * a history of bleeding disorders, peptic ulceration or anticoagulant use within the last month * pregnant or breast-feeding patients * history of known or suspected drug abuse or patients who had taken nsaids within 24 h prior to surgery
mammoscreen breast cancer risk assessment and decision aid for breast cancer screening and referrals

Conditions: Breast Carcinoma

Summary: this study collects information to implement mammoscreen for breast cancer screening and referrals. mammoscreen is a risk assessment questionnaire that identifies individuals at average and increased risk for breast cancer and guides their screening decisions.

primary objectives: i. uptake of mammoscreen (the proportion of women who enroll and use mammoscreen, also referred to as reach. ii. identification of women with above-average risk for breast cancer by mammoscreen integrated with the electronic health record (ehr). secondary outcomes: i. rates of mammography screening referral. ii. screening completed and mammography results stratified by risk category. iii. among those who meet criteria, genetic counseling referral, visit completed and genetic test done. outline: clinical staff: during development some clinical team members will participate in usability testing (up to 30 minutes) of the electronic health record interface with mammoscreen. some participants will undergo training sessions of about 20 minutes, then participate in interviews lasting up to 30 minutes at baseline prior to mammoscreen launch. clinical staff also participate in interviews up to 30 minutes after mammoscreen launch during years 2-4. participants complete surveys during the maintenance phase about six months after the last reminders are sent. patients: patients (enrolled from ohsu imc) participate in interviews lasting up to 1 hour. patients medical records are reviewed. patients will be invited via mychart to use the mammoscreen. reminders will be sent via mychart to non-respondents at 2 and 4 weeks. patients will use mammoscreen one time right after enrollment. some patients may also participate in interviews up to 1 hour each during years 3-5.

Eligibility criteria:
inclusion criteria: * women between the ages of 40 and 74 * enrolled in mychart * able to read english exclusion criteria: * personal history of breast or ovarian cancer * currently pregnant * currently in hospice
risk factors for mortality in cases of obstructed left colonic carcinoma

Conditions: Risk Factors for Mortality in Cases of Obstructed Left Colonic Carcinoma

Summary: seeking to identify risk factors leading to mortality in obstructed left cancer colon


Eligibility criteria:
inclusion criteria: * patient aged above 18 years admitted at mansoura university hospitals complaining from intestinal obstruction due to obstructed left sided carcinoma. exclusion criteria: * treatment with non-surgical intervention or spontaneous relief of obstruction
sleep and neuropathic pain - intervention study on pregabalin

Conditions: Neuropathic Pain; Insomnia; Sleep Disorder

Summary: the goal of this clinical study is to study sleep and its microstructure in neuropathic pain patients who have or who do not have a clinically significant sleep disturbance, before and during (after 1-month stabile dosage) pregabalin treatment. to find out whether reduced pain by pregabalin associates with improved sleep quality; to study, using resting state fmri, brain network connectivity and the volume of the choroid plexus before and during pregabalin treatment (after dosage stable for one month) at baseline and during stabile treatment with pregabalin, and to compare the usability and reliability of sleep-related information collected with sleep diaries, actigraphy, ibuttons, and ambulatory polysomnography in peripheral painful neuropathy patients. the main questions it aims to answer are: * is pregabalin more efficacious in neuropathic pain patients who suffer from insomnia compared to those with no clinically meaningful sleep disturbance? * does sleep disturbance due to pain associate with brain network connectivity and may these changes be reversed by pregabalin treatment? participants will * fulfill e-questionnaires and keep sleep diary before and after 1month stabile pregabalin intervention * before and after 1-month stabile pregabalin medication: 1-week actiwatch monitoring, ibutton (1 day and night), ambulatory polysomnography (1 night), brain fmri. researchers will compare patients with high isi score patients to see if they benefit more from pregabalin treatment than those with low isi score.

this is a clinical study to analyze sleep and pain and their response to pregabalin in 40 patients aged 18 to 75 years with chronic (duration\>3 months) moderate to severe pain (nrs ≥ 4/10) due to peripheral neuropathy. the investigators divide patients to two groups according to scores in isi: the ones with clinically significant insomnia with score 15 or more (isi high) and the ones without marked insomnia with score 14 or lower (isi low). sleep will be assessed by a sleep diary, ibutton, polysomnography and 1-week actiwatch monitoring before and after 1-month stabile pregabalin dosage. additionally, at these time points, several questionnaires regarding pain, sleep, mood, and quality of life and functional brain mri will be performed. at pregabalin administration, the dose is added three to four day intervals, if tolerated by the patient. after a maximum tolerated dose has been stable for 1 month, the sleep studies, questionnaires, and brain fmri are repeated. the study duration is about 3 months.

Eligibility criteria:
inclusion criteria: * chronic (duration \> 3 months) painful peripheral neuropathy * pain moderate to severe (nrs ≥ 4/10) during the past week exclusion criteria: * psychotic depression, clinically significant bipolar disorder * contraindication for performing brain fmri (metal in the body etc)

Keywords: polysomnography actigraphy fmri pregabalin neuropathic pain
combivent® cfc metered dose inhaler (mdi) in moderate to severe asthma

Conditions: Asthma

Summary: the purpose of this study is to demonstrate the superior bronchodilator efficacy of inhaled combivent® cfc mdi vs. albuterol hfa mdi in moderate to severe asthma patients.


Eligibility criteria:
inclusion criteria: * patient greater than or equal to 18 years of age, * non-smokers, * diagnosed with asthma, with an fev1 less than or equal to 70 percent of predicted normal, * stable use of beta agonist * daily use of inhaled steroids for one year exclusion criteria: * patients with other significant diseases other than asthma, requiring oxygen, * intubated within 5 years, * asthma exacerbation within 6 weeks of trial, * use of unstable doses (greater than 10 mg/day of prednisone or equivalent) of steroids, * participating in another interventional trial
graft-versus-host disease associated myelosuppression

Conditions: Abnormal Hematopoiesis; Allogenic Disease; Graft vs Host Disease

Summary: the objective is to measure the frequency, functionality and phenotype of bone marrow-derived mesenchymal stromal cells in patients after allogeneic hematopoietic stem cell transplantation. furthermore, the immune cell infiltrate of the bone marrow will be monitored at the same time. these results will be correlated with the extent of cytopenia and clinical graft-versus-host disease grading.


Eligibility criteria:
inclusion criteria: * age \>18 * acute myeloid leukemia * myelodysplastic syndrome * hematopoietic stem cell transplantation exclusion criteria: * not willing to take part

Keywords: myelosuppression mesenchymal stromal cells
neo-angiogenesis in inguinal henia implant proflor

Conditions: Inguinal Hernia

Summary: the investigation is aimed at specifically demonstrating the ingrowth of newly formed vascular elements within proflor, a 3d dynamic responsive implant for inguinal hernia repair

biopsy specimen were excised at defined postoperative stages from patients who underwent hernia repair with the 3d prosthesis named proflor. scope of the study was to determine the presence, quantity and quality of the vascular elements ingrowth within the implant fabric. histology revealed the presence of multiple angiogenetic clusters that, starting from the early stage post-implantation, increased in number and degree of maturation. in the long term, the detected vascular components assumed the typical aspect of mature veins and arteries complete in all components. the development of fully developed vascular structures, ingrowing together with other components of the abdominal wall already described in literature, seems to finalize a regenerative response. this kind of behavior, being the expected result from a device intended for the cure of inguinal hernia and its degenerative source, seems to be coherent with the pathogenesis of the disease.

Eligibility criteria:
inclusion criteria: * patients who underwent inguinal hernia repair with the 3d dynamic responsive device named proflor * patients undergoing recurrent inguinal hernia repair after primary repair with the 3d dynamic responsive device named proflor * patients undergoing surgical procedure in the groin area after inguinal hernia repair with the 3d dynamic responsive device named proflor exclusion criteria: * immunosoppressive therapy, \> asa 4 classification

Keywords: hernia implants biologic response neo-angiogenesis regenerative scaffolds
trial of bilateral sagittal split osteotomy induced paresthesia using ultrasonic vs. reciprocating saw instrumentation

Conditions: Surgical Complication; Paresthesia; Fracture; Nerve Injury; Nerve Entrapments; Mandibular Nerve Injuries; Mandibular Hypoplasia; Mandibular Retrognathism; Mandibular Hyperplasia; Mandibular Prognathism

Summary: the aim of this prospective study is to analyze the postoperative paresthesias experienced in patients who undergo bilateral sagittal split osteotomies (bsso) using an ultrasonic saw, versus a reciprocating saw. patients included in the study are ages 15-45 scheduled to undergo bsso surgery at the university of california, san francisco. one side of the patient's mandible will be instrumented with either the stryker sonopet ultrasonic saw or traditional reciprocating saw, while the other side will receive the remaining intervention (determined via randomization on the day of surgery). patient paresthesias will then be analyzed on each side for 3 months postoperatively (at postoperative days: 1, 7, 14, 28, and 84). sensory examinations will be carried out by blinded examiners using von frey hairs and two point discrimination testing. patients will also subjectively rate their sensation on each side. the results will then be analyzed to determine if patient paresthesias, including the severity and duration, differed depending on which instrument was used, the ultrasonic or reciprocating saw.


Eligibility criteria:
inclusion criteria: * must be undergoing bilateral sagittal split osteotomy surgery with dr. saghezchi at ucsf * must agree to return for all follow up visits. * must not have any preexisting v3 nerve paresthesia * must be below the age of 45. exclusion criteria: * persons with preexisting v3 nerve paresthesias * pre-pubertal children will be excluded (per routine practice for this type of surgery). * patients with syndromic genetic conditions that demonstrate clearly different anatomy in the two sides of their jaws will be excluded since the two sides may not be "exchangeable".

Keywords: paresthesia bsso bilateral saggital split osteotomy unfavorable split unfavorable fracture inferior alveolar nerve reciprocating saw ultrasonic saw pair matched randomized control trial
the protective effect of mask wearing against respiratory tract infections

Conditions: COVID-19; Respiratory Tract Infections

Summary: in this trial the researchers plan to recruit 4,000 volunteers to be randomly allocated either wearing face masks in public spaces where they are close to other people, or not wear face masks in such circumstances. for each participant the trial period is 2 weeks, after which they will be asked to complete a brief questionnaire which includes questions about whether they experienced the common cold, influenzas or covid-19 symptoms during the trail period.

this study is a pragmatic, two-armed cluster randomized superiority trial including participants in norway. participants will be randomized to one of the following two arms: control group or medical masks in a 1:1 ratio. the primary outcome is self-reported respiratory infection. the intervention is to ask participants in the intervention groups to wear face masks when close to others outside their home, e.g., in public spaces like shopping centres, and streets and on public transport. the control group will be asked not to wear face masks when close to others outside their home, e.g., in public spaces like shopping centres, and streets and on public transport. participants will continue to use, or not use, face masks at work independent of which group they are allocated to. the trial will be fully remote and without any personal interaction between investigators and participants. the researchers aim to include about 4,000 participants to have a statistical power of 80% to detect a relative risk reduction of 30% for the primary outcome.

Eligibility criteria:
inclusion criteria: * are at least 18 years of age * are willing to be randomized to wear, or not to wear, face masks outside their home when close to others for a 14-day period * provide informed consent exclusion criteria: * none
surgical offloading procedures for diabetic foot ulcers

Conditions: Diabetic Foot Ulcer

Summary: 100 consenting subjects with texas grade 1a diabetic foot ulcers will be randomized to surgical offloading or non-operative offloading.

background: diabetic foot ulcers are frequently related to elevated pressure under a bony prominence. conservative treatment includes offloading with orthopaedic shoes and custom made orthotics or plaster casts. while casting in plaster is usually effective in achieving primary closure of foot ulcers, recurrence rates are high. minimally invasive surgical offloading that includes correction of foot deformities has good short and long term results. the surgery alleviates the pressure under the bony prominence, thus enabling prompt ulcer healing, negating the patient's dependence on expensive shoes and orthotics, with a lower chance of recurrence. the purpose of this protocol is to compare offloading surgery (percutaneous flexor tenotomy, mini-invasive floating metatarsal osteotomy or keller arthroplasty) to non-surgical treatment for patients with diabetic foot ulcers in a crossover designed rct. methods: 100 patients with diabetic neuropathy related foot ulcers (tip of toe ulcers, ulcers under metatarsal heads and ulcers under the hallux interphalangeal joint) will be randomized (2:3) to a surgical offloading procedure or best available non-surgical treatment. group 1 (surgery) will have surgery within 1 week. group 2 (controls) will be prescribed an offloading cast applied for up to 12 weeks (based on clinical considerations). following successful offloading treatment (ulcer closure with complete epithelization) patients will be prescribed orthopaedic shoes and custom made orthotics. if offloading by cast for at least 6 weeks fails, or the ulcer recurs, patients will be offered surgical offloading. follow-up will take place till 2 years following randomization. outcome criteria will be time to healing of the primary ulcer (complete epithelization), time to healing of surgical wound, recurrence of ulcer, time to recurrence and complications. discussion: the high recurrence rate of foot ulcers and their dire consequences justify attempts to find better solutions that the non-surgical options available at present. to promote surgery, randomized controlled trial (rct) level evidence of efficacy is necessary.

Eligibility criteria:
inclusion criteria: * single texas a1 or a2 ulcer. * ulcer attributable to an anatomic deformity. exclusion criteria: * unable to understand language of informed consent. * ischemia.
nociceptin concentration in synovial fluid and plasma

Conditions: Pain; Osteoarthritis

Summary: nociceptin/orphanin is a novel opioid peptide system associated with inflammatory response. currently is it uncertain as to the presence of absence of nociceptin in synovial fluid of patients. nociceptin levels will be measured pre-operatively and post-operatively in plasma levels of patients receiving primary total knee arthroplasty. nociceptin levels will also be measured in synovial fluid levels prior to surgical manipulation.

this is a prospective observational study where nociceptin levels will be drawn from the patient's serum as well as from the patient's synovial fluid. the blood draws will be completed by the anesthesia team and the synovial fluid and tissue will be obtained by the orthopedic team. the initial blood draw will be in the preoperative area and the second blood draw will be five minutes after the release of the tourniquet. the synovial fluid will be drawn by the surgeon with the first incision. there will be no randomization nor control group. endpoints: 1. the level or absence of nociceptin in synovial fluid in patients receiving total knee primary arthroplasty will be measured via elisa in picograms per volume. 2. the level or absence of nociceptin in plasma in patients receiving total knee primary arthroplasty both in the preoperative period (less than 1 hour prior to surgery and 5 minutes after the tourniquet is removed) via elisa in picograms per volume. 3. determine the changes if any of nociception plasma levels during the perioperative course of patients receiving total primary knee arthroplasty. secondary study endpoints: 1. determine the effect if present of history of chronic pain and opioid use on the levels of nociception present in patients' synovial fluid and plasma receiving primary total knee arthroplasty. 2. determine the effect if present of demographic factors on the levels of nociception present in patients' synovial fluid and plasma receiving primary total knee arthroplasty

Eligibility criteria:
inclusion criteria: * receiving a primary knee joint arthroplasty by dr. davis ages 18-80 years hemodynamically stable no joint or other types of infection informed consent received and signed no prior joint arthroplasty at the current surgical site no other surgical intervention planned exclusion criteria: * prior knee arthroplasty at site outside of desired age range pregnant current infection in joint or other location no desire to participate
catheter ablation in congenital heart disease: french national prospective registry

Conditions: Congenital Heart Disease; Arrhythmia

Summary: arrhythmias represent one of the main late complications in patients with congenital heart disease. atrial arrhythmias are associated with a significant morbidity and are the first cause of urgent hospitalization, and sudden death from ventricular arrhythmias is a leading cause of death in this population. the exponential increase of the number of patients with congenital heart disease and the improvement of ablative technologies are associated with a significant increase of the number of catheter ablation procedures. most of available studies are retrospective or include a limited number of patients. the aim of this study is to assess the efficacy of catheter ablation in patients with congenital heart disease through a national prospective registry. secondary objectives are i) to identify factors associated with catheter ablation efficacy in different cardiac defects, ii) to describe complications associated with catheter ablation in this specific population, and iii) to assess the impact of catheter ablation on quality of life of patients with congenital heart disease.


Eligibility criteria:
inclusion criteria: * all patients with congenital heart disease referred for catheter ablation exclusion criteria: * absence of patient's consent * patient under guardianship or curatorship * pregnant woman

Keywords: catheter ablation
study evaluating tigecycline versus imipenem/cilastatin in hospital-acquired pneumonia

Conditions: Bacterial Pneumonia

Summary: to compare the efficacy and safety of the tigecycline regimen with that of the imipenem/cilastatin regimen in subjects with nosocomial pneumonia.


Eligibility criteria:
inclusion criteria: * male or female subjects over 18 years of age. bulgaria only: male or female subjects over 18 years of age and under 70 years of age. * subjects known or suspected to have acute hospital-acquired pneumonia. exclusion criteria: * presence of any of the following pulmonary conditions: cystic fibrosis; pulmonary malignancy (either primary or metastatic); known bronchial-obstructive or post obstructive pneumonia; pulmonary abscess; empyema; known or suspected active tuberculosis; bronchiectasis; sarcoidosis; known or suspected pulmonary infection caused by pneumocystis carinii, mycobacteria, fungi, parasites, or viruses (subjects with copd are not excluded) * suspected or known legionella infection * concurrent hemodialysis, hemofiltration, peritoneal dialysis, or plasmapheresis

Keywords: pneumonia
non-interventional study with pomalidomide (imnovid®)

Conditions: Multiple Myeloma

Summary: the purpose of this non-interventional study is to collect data on the efficiency and safety of pomalidomide in combination with dexamethasone in the routine application


Eligibility criteria:
inclusion criteria: * patients with relapsed or refractory multiple myeloma patients must have received at least two prior lines of treatment (induction therapy followed by stem cell transplantation ± maintenance therapy is considered one prior therapy) and must have progressed under the most recent therapy regimen * adult male and female patients (at least 18 years with no upper age limit) * written informed consent to data collection and pseudonymized data transfer * the conditions of the pregnancy prevention programme must be fulfilled for all patients unless there is reliable evidence that the patient does not have childbearing potential (see summary of product characteristics imnovid®) * other criteria according to summary of product characteristics imnovid® exclusion criteria: * missing patient's informed consent * pregnant or breast-feeding women * male patients, not capable of complying the required preventive measures (see summary of product characteristics imnovid®) * other criteria according to summary of product characteristics imnovid®

Keywords: pomalidomide, imnovid, dexamethasone, poseidon, multiple myeloma, daily routine, secondary malignancies, germany, non-interventional study, safety,